Senior Manager, Technical Product Owner

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🔥 4 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $150k - $180k / year

⏰ Full Time

🟠 Senior

⚒️ Technical Product Manager (TPM)

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501 - 1000 employees

Founded 1987

💰 Debt financing on 2017-06

Search is one of the UK’s leading multi-discipline recruitment agencies, covering more than 14 different specialisms and operating from 13 offices nationwide.

📋 Description

• Support the technical lifecycle management of Atzumi™ • Serve as technical owner and subject-matter expert across API and excipients, bulk formulation, device components, filling and assembly, and secondary packaging • Establish operational objectives, policies, and procedures for technical product ownership activities • Serve as technical interface with contract manufacturing organizations and suppliers • Develop and execute technical improvement plans to improve robustness, reduce variability and defects, improve yield, strengthen supply continuity, and lower cost while maintaining quality and compliance • Maintain the product and process knowledge base, including critical material attributes, critical quality attributes, critical process parameters, process dependencies, technical risks, and manufacturing-process rationale • Establish and govern continued process verification, including data collection, performance trending, alert and action-limit review, and action-plan management • Provide technical direction and support for deviations, batch failures, complaints, nonconformances, supplier defects, atypical trends, and recurring performance issues • Manage manufacturing and supplier changes and support post-approval changes, qualifications, stability, batch-record updates, and impact assessments • Support maintenance and reliability of Satsuma-owned manufacturing equipment, including equipment changes, reliability improvements, maintenance and obsolescence planning, critical-spare strategies, and automation or software-change assessments • Support regulatory inspections, partner audits, and internal inspection-readiness activities • Author and review technical content for post-approval submissions, regulatory commitments, health-authority questions, audits, and inspections • Partner with Quality, Regulatory Affairs, Supply Chain, Commercial, and external partners to prioritize technical work, support supply decisions, and implement changes • Drive larger technical improvement projects spanning multiple organizational areas • Proactively assume additional responsibilities, initiatives, and special projects as business needs evolve • Report to the Senior Director, Operations

🎯 Requirements

• Bachelor’s degree in chemical, mechanical, biomedical, pharmaceutical, manufacturing, or related engineering; pharmaceutical sciences, chemistry, or another relevant technical discipline • 7+ years of experience in pharmaceutical, biotechnology, medical device, combination-product, MSAT/MS&T, process engineering, product stewardship, or technical operations roles, including support of commercial or late-stage products • Experience supporting pharmaceutical or drug-device combination products across multiple unit operations and/or external manufacturing partners • Working knowledge of process validation, continued process verification, process capability, product quality review, deviation and CAPA systems, change control, risk management, and post-approval lifecycle requirements • Experience with combination-product design controls, component specifications and drawings, supplier manufacturing processes, device assembly, and device risk-management documentation is preferred • Experience leading investigations and improvement projects, statistical analysis, process-capability assessment, and root-cause analysis • Working knowledge of applicable FDA and ICH guidelines and requirements • Strong project-management, collaboration, and communication skills • Ability to coordinate CMOs and suppliers, manage multiple priorities, and communicate technical risks and recommendations clearly • Experience with dry-powder formulations, nasal or inhalation delivery systems, unit-dose devices, spray-drying, powder filling, automated device assembly, or secondary packaging is preferred • Ability to travel to domestic and international manufacturing and supplier sites as business needs require, anticipated at up to 25% • Proven ability to advise teams on moderately complex matters and contribute to accountability for outcomes impacting the business segment • An equivalent combination of education, training, and relevant experience may substitute for stated qualifications • Must satisfy applicable work authorization and employment eligibility requirements

🏖️ Benefits

• Health Insurance • Dental & Vision Insurance • Healthcare & Dependent Care FSA • Employee Assistance Program (EAP) • 401(k) Savings Plan • Long-term Incentive Plan • Life Insurance • Accident & Disability Insurance • Telemedicine • Generous Paid Time Off • Company Holidays • Remote work arrangement • Equal opportunity employment

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